Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696107
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2020-12-23
Brief Title:
Effectiveness of Coping Strategies on the Control of Chronic Non-Cancer Pain and Quality of Life CNCP_CopQol
Sponsor:
Hospital San Juan de Dios del Aljarafe de Sevilla
Organization:
Hospital San Juan de Dios del Aljarafe de Sevilla
Study Overview
Official Title:
Effectiveness of Coping Strategies on the Control of Musculoskeletal Chronic Non-Cancer Pain and Quality of Life A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CNCP_CopQol
Brief Summary:
Introduction and objectives Non-pharmacological interventions in patients with musculoskeletal chronic non-cancer pain mCNCP are positioning themselves as an essential pillar in treatment along with pharmacological and interventional treatment Training the patient in psycho-educational interventions focused on the neuroscience of pain and accompanying them towards a better coping of their disease can decrease the perception of pain and improve their quality of life A previous pilot study developed by the researchers about this type of interventions identified as relevant data an improvement in the quality of life QoL of patients with mCNCP with a significant decrease in pharmacological consumption and a high degree of satisfaction on the part of the user through the analysis of PROMs patient-reported outcome measures The main objective of this study is to know the effectiveness in the perception of pain through the Verbal Numerical Rating Scale VNRS and in the quality of life through the EuroQol-5D EQ-5D questionnaire of a psychoeducational intervention focused on emotional coping strategies in patients with mCNCP in the Primary Care Centres of Public Health System of Aljarafe-Sevilla Norte Area Spain Secondarily the consumption of health resources associated with mCNCP the adherence to treatment the influence of social emotional and family variables will be studied by the researchers in the two groups of patients on each telephone assessment
Methodology Prospective randomized triple-blind patient investigator and analysis and controlled clinical trial Participants with mCNCP in follow-up in Primary Care without clinical control with the treatment scheduled and who agree to participate in the study will be randomized by blocks permuted to receive treatments and standard care control group or these same care plus a psychoeducational intervention experimental group This intervention consists of an emotional self-regulation training program of four face-to-face sessions of 3 hours each over a four-week period The study will include 144 participants 72 for each arm Patient follow-up will be telephone at the time of inclusion at month three and six months A descriptive and multivariate analysis will be done with the patients research data associated with pain or QoL post-intervention
Ethics and dissemination The study will be carried out following the Helsinki Declaration and is approved by the Committee on Ethics of Research of Virgen Macarena- Virgen del Rocio university hospitals in Seville Spain code 1589-N-19 The results of the trial will be published under CONSORT regulations and SPIRIT guideline
Methodology Prospective randomized triple-blind patient investigator and analysis and controlled clinical trial Participants with mCNCP in follow-up in Primary Care without clinical control with the treatment scheduled and who agree to participate in the study will be randomized by blocks permuted to receive treatments and standard care control group or these same care plus a psychoeducational intervention experimental group This intervention consists of an emotional self-regulation training program of four face-to-face sessions of 3 hours each over a four-week period The study will include 144 participants 72 for each arm Patient follow-up will be telephone at the time of inclusion at month three and six months A descriptive and multivariate analysis will be done with the patients research data associated with pain or QoL post-intervention
Ethics and dissemination The study will be carried out following the Helsinki Declaration and is approved by the Committee on Ethics of Research of Virgen Macarena- Virgen del Rocio university hospitals in Seville Spain code 1589-N-19 The results of the trial will be published under CONSORT regulations and SPIRIT guideline
Detailed Description:
1 BACKGROUND AND RATIONALE
Many people with mCNCP experience stress fear and depression These emotions mental states and their associated behaviours often act as aggravating factors amplifying the perception of pain 1-3 As a result the same stimulus produces more suffering and begins a vicious circle In this context the acceptance and engagement therapy ACT and mindfulness-based stress reduction MBSR can be very helpful in managing chronic pain These practices allow the patients to focus on participating in valuable activities and finding personally relevant objectives improving their coping in this situation
Based on systematic reviews the investigators can confirm that body-mind therapies especially MBSR and pain neuroscience education show benefits in a different kind of noncancer chronic pain in the adult such as reducing the severity of pain and functional limitation maintaining the positive effects in the long term On the other hand related to a growing interest in reducing the use of opioid medications it is also important to determine if one of the results of psychological approaches is the decrease in drug use and as a consequence a decrease in health cost per patient Although this is one of the benefits assumed studies about the association between pain management or self-control interventions and dependence on painkillers are lacking There are not enough data about the behavioral intervention effects on the use of pain medication but initially points to a reduction Therefore it is necessary to focus on the management of the mCNCP integrally incorporating non-pharmacological therapies that provide the patients with skills to face the illness and above all empower themselves through information and training the self-care
Researchers propose this clinical trial to demonstrate the effectiveness of a psychoeducational intervention focused on emotional coping in the control of symptoms QoL and consumption of analgesics and health resources in patients with mCNCP
2 RESEARCH QUESTION
The early and integratively detection and approach of mCNCP are the main tools to decrease its prevalence and negative effects on both the patient life and the Health System Scientific evidence supports body-mind therapies and patient education in pain neuroscience that enable a positive adaptive response that appears to improve functionality and QoL in people affected by mCNCP That is why the research question directed by this investigation is Can a psychoeducational intervention focused on emotional coping reduce the pain perception and improve the QoL of adult patients with mCNCP treated in Public Primary Health Centre of the Aljarafe-North Seville Area
3 OBJECTIVES
31 Main objective Know the effectiveness in pain perception through VNRS and QoL through the EQ-5D scale of psychoeducational intervention focused on emotional coping strategies in participants with mCNCP in the Public Health Centers of the Aljarafe-North Seville Area
32 Specific objectives
Identify the sociodemographic clinical psychological and functional characteristics of mCNCP patients based on disease type and sex
Compare scores on pain perception and QoL between the workshop group and the control group before the intervention and throughout follow-up
Evaluate changes in analgesic pharmacological consumption in conventionally treated participants versus those who also receive psychoeducational intervention focused on emotional coping and self-control techniques
Analyse the frequentation of health services and the number of days of work disability caused by the intensification of pain in conventionally treated patients compared to those receiving the psychoeducational intervention
Assess the influence of global family functioning and emotional coping on the experience of pain through the Family Apgar Scale and the Reduced Chronic Pain Coping Questionnaire respectively
Assess the impact of the intervention on sleep quality and co-existing sleep disorders
Detect predictors of the effectiveness of psychoeducational intervention focused on emotional coping and identify profiles of patients more sensitive to modify the pain perception or quality of life through psychoeducational intervention
4 SAMPLE SIZE
Based on a previous pilot study and accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 72 subjects are required in the first group and 72 in the second to detect a difference equal to or greater than 007 on 1 on the EQ-5D scale between the two groups The common standard desviation is assumed to be 016 and a correlation coefficient between the initial and final measurement of 061 A loss to follow-up rate of 10 has been estimated Total 144
5 RECRUITMENT
Participants will be recruited for clinical trials at Primary Care Centres of Public Health System of Spain through the identification in the Chronic Non-Cancer Pain patient registry database
6 ASSIGNMENT OF INTERVENTION SEQUENCE GENERATION Participants will be randomly assigned to a control or experimental group by permutations of two elements the number of groups taken four by four the size of the block AABB ABAB ABBA BAAB BABA and BBAA Finally the blocks are randomly ordered from one to six and the participants are successively assigned to the corresponding option completing the blocks in the order established at random In this way with every four participants assigned the size of the two groups will be equalized
7 DATA MANAGEMENT
In this clinical trial all data will be entered electronically except for comments made by participants at the end of each workshop in the intervention group Participant data will be stored in numerical order in a secure location accessible only to professionals who enter and analyze the data Participant files will be kept for a period of 3 years after completion of the study
8 STATISTICAL ANALYSIS
First a descriptive analysis of all the variables will be carried out Qualitative variables will be presented by absolute and relative frequencies and quantitative variables by the mean and standard deviation or median and interquartile range depending on whether or not a normal distribution is followed
In the second stage an intention-to-treat analysis will be developed To perform the analysis between different variables or factors that could influence the results the Chi-square test or Fishers exact test will be used for qualitative variables and the Students t-test and ANOVA or U of Mann Whitney and Kruskal Wallis for quantitative variables depending on whether a normal distribution is followed To explore the relationship between the dependent variables and the participants sociodemographic psychosocial and clinical characteristics the appropriate tests will be used in each situation Students T-test ANOVA Pearsons correlation coefficient or the non-parametric alternatives if necessary U of Correlation of Mann Whitney Kruskal Wallis and Spearman For the comparative analysis between the two intervention groups and in the repeated samples of each patient contrast tests will be used for independent and related samples respectively
To control the possible confounding effect of some variables andor the possible interactions on the global score of EQ-5D and VNRS multivariate regression models will be run taking into account the linear or non-linear relationship of the possible predictors with the outcomes The analyzes will also be carried out with relevant study strata such as the patients profile detected from the cluster analysis according to variables associated with the characteristics of pain and its etiopathogenesis
The level of statistical significance will be set at p less than 005 The statistical analysis will be carried out with the SPSS package version 190 and R Studio
9 COMMITTEES
- Principal Investigators and Research Physician Design of the protocol registration and conduct of the trial Preparation of investigators brochure and case report forms Organization of meetings of the steering committee Publication of study reports
- Lead Investigators In each participating Primary Health Center the principal investigator Doctor of Family Medicine will be identified which will be responsible for the identification patient information and recruitment
- Data manager Data entry analysis and maintenance of the computer system used
- Patient Security Committee Within the team a healthcare professional and an expert patient will control the development of the clinical trial ensuring that is safe for the volunteers and that the project materializes as designed A quarterly report will be issued reflecting a degree of compliance from 0 to 5 where 0 is the total absence of protocol compliance and 5 is absolute compliance This commission will also be the communication vehicle between the volunteers and the research team for the resolution of doubts or attention to suggestions
- Management Committee Principal Investigators Monitor Medical Investigator Administrator Study planning randomization organization of meetings provide annual development report and ethics committee
10 DATA MONITORING
101 Formal committee
Although this trial focuses on a psychoeducational intervention investigators will conduct quarterly reviews with the Patient Safety Committee and the Management Committee to assess patient feedback If the information provided by the patients or the data analyzed at the time negatively affects the patients clinic the appropriate modifications are made or in your case the suspension
102 Intermediate analysis
An interim analysis on the primary endpoint will be performed when 50 of participants have been randomized and completed the 6-month follow-up An independent statistician blinded for treatment allocation will perform an interim analysis The statistician will report to the Patient Safety Committee which will decide on the continuation of the trial and will report to the central Ethics Committee
103 Auditing
The clinical trial will have a monitor who will make visits to give support and solve problems The monitor will
discuss the protocol in detail and identify and clarify any areas of weakness
audit the quality and general integrity of the data
interview researchers and coordinators
confirm that the centre has complied with the protocol requirements
verify that all adverse events were documented in the correct format and that they are consistent with the protocol definition
Verify documentation protocol and informed consent the corresponding approvals patient reports and documentation of dropouts and adverse events
The scheduling of follow-up visits will depend on patient enrollment site status and other commitments Investigators must be available to meet with monitors
11 ETHICAL ASPECTS
111 Approval of research ethics
The study design and subsequent development follow the recommendations for biomedical research in humans reflected in the Declaration of Helsinki through the World Medical Association The patient will be informed verbally and with the delivery of a written document of the characteristics of the study objectives benefits and possible derived damages Participation is voluntary and the patient will perform this right contained in the Principle of Patient Autonomy by signing the informed consent This protocol and the Informed Consent have been reviewed and approved with applicable regulations in research and human subjects by the corresponding Ethics Committee Virgen del Rocío University Hospital Seville Spain with the code 1589-N-19 after modifying a correction suggested minor update of the date of the Official Data Protection Law
112 Consent or assent
Family Medicine specialists at the Public Primary Health Center will present the trial to patients and provide a background document explaining the study Patients after receiving verbal and written information will have the opportunity to discuss or consult the information provided The family doctor will get the signed informed consent of the patients who accept to participate in the trial Information documents and consent forms are provided for all participants The information document will be kept by the patient and the informed consent with the names surnames and ID will be kept in a file with a unique password for each participating doctor Once a week two of the researchers will collect the paper documents and take them to the Research Unit of the Hospital San Juan de Dios del Aljarafe where the data will be coded and randomized once the identity of the patient is known These documents will be protected in a closed filing cabinet belonging to the Head of the Investigation Unit
As it is a psychoeducational intervention versus no intervention the patients knowledge of the group to which has been assigned could condition the responses in the evaluation To minimize biases secondary to knowledge of the assigned therapy two information sheets have been designed One of them describes in a general way what the study will consist of This will be delivered to all participants recruited by primary care physicians The second in which the workshop is described in more detail will be given only to patients who have been randomly included in the intervention group It will be delivered at the beginning of the first workshop being able to resolve any doubt in this regard At this point the patient can drop out of the study if they disagree
12 CONFIDENTIALITY
For the safe handling of patient information
1 The participants medical record number will be coded and depersonalized replacing the participants identification information with an unrelated number
2 The data and the link code will be stored in a separate database using encrypted digital files within password-protected folders and storage media to which only the statistical professional of the study who only participates in the analysis of the data will have access data The Management Committee will have access to the data to carry out audits without knowing the link code of each patient and therefore the identity
3 The confidentiality of the data will also be preserved when the data is transmitted over the Internet through the virtual private network of Hospital San Juan de Dios del Aljarafe
The treatment communication and transfer of personal data of all participating subjects will comply with the provisions of Organic Law 32018 of December 5 Protection of Personal Data and Guarantee of Digital Rights Following the aforementioned legislation the patient can exercise the rights of access modification opposition and cancellation of the data for which they must contact the Patient Safety Committee The data collected for the study will be identified by a code and only a professional can relate this data to the patient and the medical history Personal data will be used exclusively for scientific or statistical research purposes and will not be communicated or transferred to third parties nor will they be subject to automated decisions or international transfers Personal data once they are no longer necessary will be kept under the legally established deadlines after which they will be deleted Therefore the identity of the patient will not be revealed to anyone except for exceptions such as a medical emergency or a legal requirement The processing of personal data will comply with the requirements described in the RGPD General Data Protection Regulation
If at any time the patient considers that the use of the data does not correspond to that described above he or she may exercise the affected rights in the terms provided by the regulations as well as file a claim with the Control Authority Data Protection Agency In this sense patients can go to Avenida San Juan de Dios s n CP 41930 Bormujos Sevilla or contact our Data Protection Delegate through the email C15_DPOsjdes
In compliance with article 12 of Law 142007 of July 3 on Biomedical Research which establishes as principles and guarantees in this field of action the requirement of a favourable report issued by the Research Ethics Committee before the development of any project of research on human beings this project and all the related material that was provided to the subject have been sent to the CEIC of the University Hospital Virgen del Rocío for evaluation and after the indicated corrections the favourable opinion dated 23102019 and the Internal Code of the project 1589-N-19 have been given
As it is a non-pharmacological clinical trial with a low level of intervention and no commercial purpose according to sections 2 and 4 of article 9 of Royal Decree 10902015 on the regulations on methodology and regulation of clinical trials in Spain contracting insurance would not be mandatory
13 DECLARATION OF INTERESTS
The authors have no conflicts of interest to declare
Many people with mCNCP experience stress fear and depression These emotions mental states and their associated behaviours often act as aggravating factors amplifying the perception of pain 1-3 As a result the same stimulus produces more suffering and begins a vicious circle In this context the acceptance and engagement therapy ACT and mindfulness-based stress reduction MBSR can be very helpful in managing chronic pain These practices allow the patients to focus on participating in valuable activities and finding personally relevant objectives improving their coping in this situation
Based on systematic reviews the investigators can confirm that body-mind therapies especially MBSR and pain neuroscience education show benefits in a different kind of noncancer chronic pain in the adult such as reducing the severity of pain and functional limitation maintaining the positive effects in the long term On the other hand related to a growing interest in reducing the use of opioid medications it is also important to determine if one of the results of psychological approaches is the decrease in drug use and as a consequence a decrease in health cost per patient Although this is one of the benefits assumed studies about the association between pain management or self-control interventions and dependence on painkillers are lacking There are not enough data about the behavioral intervention effects on the use of pain medication but initially points to a reduction Therefore it is necessary to focus on the management of the mCNCP integrally incorporating non-pharmacological therapies that provide the patients with skills to face the illness and above all empower themselves through information and training the self-care
Researchers propose this clinical trial to demonstrate the effectiveness of a psychoeducational intervention focused on emotional coping in the control of symptoms QoL and consumption of analgesics and health resources in patients with mCNCP
2 RESEARCH QUESTION
The early and integratively detection and approach of mCNCP are the main tools to decrease its prevalence and negative effects on both the patient life and the Health System Scientific evidence supports body-mind therapies and patient education in pain neuroscience that enable a positive adaptive response that appears to improve functionality and QoL in people affected by mCNCP That is why the research question directed by this investigation is Can a psychoeducational intervention focused on emotional coping reduce the pain perception and improve the QoL of adult patients with mCNCP treated in Public Primary Health Centre of the Aljarafe-North Seville Area
3 OBJECTIVES
31 Main objective Know the effectiveness in pain perception through VNRS and QoL through the EQ-5D scale of psychoeducational intervention focused on emotional coping strategies in participants with mCNCP in the Public Health Centers of the Aljarafe-North Seville Area
32 Specific objectives
Identify the sociodemographic clinical psychological and functional characteristics of mCNCP patients based on disease type and sex
Compare scores on pain perception and QoL between the workshop group and the control group before the intervention and throughout follow-up
Evaluate changes in analgesic pharmacological consumption in conventionally treated participants versus those who also receive psychoeducational intervention focused on emotional coping and self-control techniques
Analyse the frequentation of health services and the number of days of work disability caused by the intensification of pain in conventionally treated patients compared to those receiving the psychoeducational intervention
Assess the influence of global family functioning and emotional coping on the experience of pain through the Family Apgar Scale and the Reduced Chronic Pain Coping Questionnaire respectively
Assess the impact of the intervention on sleep quality and co-existing sleep disorders
Detect predictors of the effectiveness of psychoeducational intervention focused on emotional coping and identify profiles of patients more sensitive to modify the pain perception or quality of life through psychoeducational intervention
4 SAMPLE SIZE
Based on a previous pilot study and accepting an alpha risk of 005 and a beta risk of 02 in a bilateral contrast 72 subjects are required in the first group and 72 in the second to detect a difference equal to or greater than 007 on 1 on the EQ-5D scale between the two groups The common standard desviation is assumed to be 016 and a correlation coefficient between the initial and final measurement of 061 A loss to follow-up rate of 10 has been estimated Total 144
5 RECRUITMENT
Participants will be recruited for clinical trials at Primary Care Centres of Public Health System of Spain through the identification in the Chronic Non-Cancer Pain patient registry database
6 ASSIGNMENT OF INTERVENTION SEQUENCE GENERATION Participants will be randomly assigned to a control or experimental group by permutations of two elements the number of groups taken four by four the size of the block AABB ABAB ABBA BAAB BABA and BBAA Finally the blocks are randomly ordered from one to six and the participants are successively assigned to the corresponding option completing the blocks in the order established at random In this way with every four participants assigned the size of the two groups will be equalized
7 DATA MANAGEMENT
In this clinical trial all data will be entered electronically except for comments made by participants at the end of each workshop in the intervention group Participant data will be stored in numerical order in a secure location accessible only to professionals who enter and analyze the data Participant files will be kept for a period of 3 years after completion of the study
8 STATISTICAL ANALYSIS
First a descriptive analysis of all the variables will be carried out Qualitative variables will be presented by absolute and relative frequencies and quantitative variables by the mean and standard deviation or median and interquartile range depending on whether or not a normal distribution is followed
In the second stage an intention-to-treat analysis will be developed To perform the analysis between different variables or factors that could influence the results the Chi-square test or Fishers exact test will be used for qualitative variables and the Students t-test and ANOVA or U of Mann Whitney and Kruskal Wallis for quantitative variables depending on whether a normal distribution is followed To explore the relationship between the dependent variables and the participants sociodemographic psychosocial and clinical characteristics the appropriate tests will be used in each situation Students T-test ANOVA Pearsons correlation coefficient or the non-parametric alternatives if necessary U of Correlation of Mann Whitney Kruskal Wallis and Spearman For the comparative analysis between the two intervention groups and in the repeated samples of each patient contrast tests will be used for independent and related samples respectively
To control the possible confounding effect of some variables andor the possible interactions on the global score of EQ-5D and VNRS multivariate regression models will be run taking into account the linear or non-linear relationship of the possible predictors with the outcomes The analyzes will also be carried out with relevant study strata such as the patients profile detected from the cluster analysis according to variables associated with the characteristics of pain and its etiopathogenesis
The level of statistical significance will be set at p less than 005 The statistical analysis will be carried out with the SPSS package version 190 and R Studio
9 COMMITTEES
- Principal Investigators and Research Physician Design of the protocol registration and conduct of the trial Preparation of investigators brochure and case report forms Organization of meetings of the steering committee Publication of study reports
- Lead Investigators In each participating Primary Health Center the principal investigator Doctor of Family Medicine will be identified which will be responsible for the identification patient information and recruitment
- Data manager Data entry analysis and maintenance of the computer system used
- Patient Security Committee Within the team a healthcare professional and an expert patient will control the development of the clinical trial ensuring that is safe for the volunteers and that the project materializes as designed A quarterly report will be issued reflecting a degree of compliance from 0 to 5 where 0 is the total absence of protocol compliance and 5 is absolute compliance This commission will also be the communication vehicle between the volunteers and the research team for the resolution of doubts or attention to suggestions
- Management Committee Principal Investigators Monitor Medical Investigator Administrator Study planning randomization organization of meetings provide annual development report and ethics committee
10 DATA MONITORING
101 Formal committee
Although this trial focuses on a psychoeducational intervention investigators will conduct quarterly reviews with the Patient Safety Committee and the Management Committee to assess patient feedback If the information provided by the patients or the data analyzed at the time negatively affects the patients clinic the appropriate modifications are made or in your case the suspension
102 Intermediate analysis
An interim analysis on the primary endpoint will be performed when 50 of participants have been randomized and completed the 6-month follow-up An independent statistician blinded for treatment allocation will perform an interim analysis The statistician will report to the Patient Safety Committee which will decide on the continuation of the trial and will report to the central Ethics Committee
103 Auditing
The clinical trial will have a monitor who will make visits to give support and solve problems The monitor will
discuss the protocol in detail and identify and clarify any areas of weakness
audit the quality and general integrity of the data
interview researchers and coordinators
confirm that the centre has complied with the protocol requirements
verify that all adverse events were documented in the correct format and that they are consistent with the protocol definition
Verify documentation protocol and informed consent the corresponding approvals patient reports and documentation of dropouts and adverse events
The scheduling of follow-up visits will depend on patient enrollment site status and other commitments Investigators must be available to meet with monitors
11 ETHICAL ASPECTS
111 Approval of research ethics
The study design and subsequent development follow the recommendations for biomedical research in humans reflected in the Declaration of Helsinki through the World Medical Association The patient will be informed verbally and with the delivery of a written document of the characteristics of the study objectives benefits and possible derived damages Participation is voluntary and the patient will perform this right contained in the Principle of Patient Autonomy by signing the informed consent This protocol and the Informed Consent have been reviewed and approved with applicable regulations in research and human subjects by the corresponding Ethics Committee Virgen del Rocío University Hospital Seville Spain with the code 1589-N-19 after modifying a correction suggested minor update of the date of the Official Data Protection Law
112 Consent or assent
Family Medicine specialists at the Public Primary Health Center will present the trial to patients and provide a background document explaining the study Patients after receiving verbal and written information will have the opportunity to discuss or consult the information provided The family doctor will get the signed informed consent of the patients who accept to participate in the trial Information documents and consent forms are provided for all participants The information document will be kept by the patient and the informed consent with the names surnames and ID will be kept in a file with a unique password for each participating doctor Once a week two of the researchers will collect the paper documents and take them to the Research Unit of the Hospital San Juan de Dios del Aljarafe where the data will be coded and randomized once the identity of the patient is known These documents will be protected in a closed filing cabinet belonging to the Head of the Investigation Unit
As it is a psychoeducational intervention versus no intervention the patients knowledge of the group to which has been assigned could condition the responses in the evaluation To minimize biases secondary to knowledge of the assigned therapy two information sheets have been designed One of them describes in a general way what the study will consist of This will be delivered to all participants recruited by primary care physicians The second in which the workshop is described in more detail will be given only to patients who have been randomly included in the intervention group It will be delivered at the beginning of the first workshop being able to resolve any doubt in this regard At this point the patient can drop out of the study if they disagree
12 CONFIDENTIALITY
For the safe handling of patient information
1 The participants medical record number will be coded and depersonalized replacing the participants identification information with an unrelated number
2 The data and the link code will be stored in a separate database using encrypted digital files within password-protected folders and storage media to which only the statistical professional of the study who only participates in the analysis of the data will have access data The Management Committee will have access to the data to carry out audits without knowing the link code of each patient and therefore the identity
3 The confidentiality of the data will also be preserved when the data is transmitted over the Internet through the virtual private network of Hospital San Juan de Dios del Aljarafe
The treatment communication and transfer of personal data of all participating subjects will comply with the provisions of Organic Law 32018 of December 5 Protection of Personal Data and Guarantee of Digital Rights Following the aforementioned legislation the patient can exercise the rights of access modification opposition and cancellation of the data for which they must contact the Patient Safety Committee The data collected for the study will be identified by a code and only a professional can relate this data to the patient and the medical history Personal data will be used exclusively for scientific or statistical research purposes and will not be communicated or transferred to third parties nor will they be subject to automated decisions or international transfers Personal data once they are no longer necessary will be kept under the legally established deadlines after which they will be deleted Therefore the identity of the patient will not be revealed to anyone except for exceptions such as a medical emergency or a legal requirement The processing of personal data will comply with the requirements described in the RGPD General Data Protection Regulation
If at any time the patient considers that the use of the data does not correspond to that described above he or she may exercise the affected rights in the terms provided by the regulations as well as file a claim with the Control Authority Data Protection Agency In this sense patients can go to Avenida San Juan de Dios s n CP 41930 Bormujos Sevilla or contact our Data Protection Delegate through the email C15_DPOsjdes
In compliance with article 12 of Law 142007 of July 3 on Biomedical Research which establishes as principles and guarantees in this field of action the requirement of a favourable report issued by the Research Ethics Committee before the development of any project of research on human beings this project and all the related material that was provided to the subject have been sent to the CEIC of the University Hospital Virgen del Rocío for evaluation and after the indicated corrections the favourable opinion dated 23102019 and the Internal Code of the project 1589-N-19 have been given
As it is a non-pharmacological clinical trial with a low level of intervention and no commercial purpose according to sections 2 and 4 of article 9 of Royal Decree 10902015 on the regulations on methodology and regulation of clinical trials in Spain contracting insurance would not be mandatory
13 DECLARATION OF INTERESTS
The authors have no conflicts of interest to declare
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None